Frequency Therapeutics — Hearing Loss Regeneration

I guess it's all a step by step plan.
1. Divide progenitors
2. Make them hair cells
3. strengthen and establish functional signals
4. Expand areas of treatment/establish how much to give.
 
See, they're just stringing us along.

Was there even any improvement from phase 1?

Again it's all about money.

Just a con job to string it along for more what little funding they do get.

If they had anything that worked, people would be throwing money at them.

Yes I'm very mad and tired of living this HELL. If the CDC was involved things would move faster.

All these years and not one dam thing to help us.

Hell there are even meds for people with HIV and that was because of the CDC.

I'm sorry for being so upset. I'm just venting... I begged them to let me in the trial but they said NO. I'm so tired of the lies and games from these people. It's nothing but wait, wait, wait.

WAIT for what?

You have not shown anything so far.

I'm sorry for being so upset, my brain is screaming so DAMN LOUD...

Rick
The new "right to try" laws should technically allow us to get this treatment right now, so long as being driven to suicide would classify tinnitus as a fatal disease and frequencytx was willing to sell it. I emailed them and asked about that and there has been no response.
 
How can someone get the CDC involved?
We need a White House petition. I'm working with an advocate for military veterans to get it promoted when I create it.

We need to coordinate wisely because it needs 100,000 signatures in 30 days of creation. We would all have to work hard to achieve this.
 
"...If successful, the current study will position us to advance to our Phase 2a program where we'll be looking to identify and characterize a hearing restoration signal and proof of biological concept in sensorineural hearing loss." [said Carl LeBel, Ph.D., Chief Development Officer of Frequency.]

I'm guessing that would be to further specify which hearing loss subtypes may benefit, and to allow wiggle room in case of practical cure failure in trial patients, but still "2a" and not 2/3 or 3? ://
Oh well, I guess that's the way it works. Not sure why they can't do the above in this trial though.
I guess it's all a step by step plan.
1. Divide progenitors
2. Make them hair cells
3. strengthen and establish functional signals
4. Expand areas of treatment/establish how much to give.
This does show that they are very methodical and serious so I do like that.
 
Do you think they are making it themselves to be more cost efficient? There's always that possibility.

Whenever you buy something that is manufactured, you have to take into account all the machinery they've used etc.

What if Frequency Therapeutics bought the machinery and the tools to make an abundance?

I seriously doubt they are just buying and mixing shit with millions of dollars.
 
Do you think they are making it themselves to be more cost efficient? There's always that possibility.

Whenever you buy something that is manufactured, you have to take into account all the machinery they've used etc.

What if Frequency Therapeutics bought the machinery and the tools to make an abundance?

I seriously doubt they are just buying and mixing shit with millions of dollars.
From what I've read it's not really that expensive. And how much do they really need /patient? What's the volume of a cochlea?
 
"Patients received either an injection of FX-322 or a placebo in one ear with an initial follow up visit after two weeks and will continue to be monitored for the following three months"

.... Does it means that it is more than 2 weeks that they all have been injected?
 
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From what I've read it's not really that expensive. And how much do they really need /patient? What's the volume of a cochlea?

They inject the drug into the middle ear so you need the middle ear volume. It's 1cm3 so around 1ml. It travels from the middle ear into the cochlea. If this works the same like an intratympanic cortisone injection, the middle ear will be filled nearly to the maximum and you are not allowed to talk or do anything else that could open your eustachian tube, otherwise the drug will be in your stomach. (talk, swallow, yawn, ...) After some time you can open the tube again of course...but this happens automatically anway.

What I don't understand right now is why you can't take it orally if it can so easily reach your stomach? Maybe they modified a lot or I misunderstood the workflow. :)
 
"Patients received either an injection of FX-322 or a placebo in one ear with an initial follow up visit after two weeks and will continue to be monitored for the following three months"

.... So this means that it is more than 2 weeks that they all have been injected?
A single injection into middle ear of

FX-322L (0.05mL)

A single injection PlaceboL (0.05mL)

A single injection FX-322H (0.2mL)

A single injection PlaceboH (0.2mL)

The drug was assigned by chance, like flip of a coin.

-----

@Deathtotinni was supposed to do the screening and get the injection, I haven't heard anything from him since then. I was going to send him some help.

The study will last 3 to 4 months, so we might get the results by December or January.
 
They inject the drug into the middle ear so you need the middle ear volume. It's 1cm3 so around 1ml. It travels from the middle ear into the cochlea. If this works the same like an intratympanic cortisone injection, the middle ear will be filled nearly to the maximum and you are not allowed to talk or do anything else that could open your eustachian tube, otherwise the drug will be in your stomach. (talk, swallow, yawn, ...) After some time you can open the tube again of course...but this happens automatically anway.

What I don't understand right now is why you can't take it orally if it can so easily reach your stomach? Maybe they modified a lot or I misunderstood the workflow. :)
Unwanted side effects. very scary.
 
Following Frequency´s work and this thread really is a thriller.

In all my agony of tinnitus and hyperacusis, following this thread the last couple of years is the only way I still have a concept of time passing. Every day the same... All I´m doing, is waiting for this to succeed, that's all the purpose I still have in life.

Sad? Probably, yes! But it won't be after my ears are fixed. Then I´ll live like nobody has ever lived :rockingbanana:

Go Frequency Therapeutics! :pompous:
 
They inject the drug into the middle ear so you need the middle ear volume. It's 1cm3 so around 1ml. It travels from the middle ear into the cochlea. If this works the same like an intratympanic cortisone injection, the middle ear will be filled nearly to the maximum and you are not allowed to talk or do anything else that could open your eustachian tube, otherwise the drug will be in your stomach. (talk, swallow, yawn, ...) After some time you can open the tube again of course...but this happens automatically anway.

What I don't understand right now is why you can't take it orally if it can so easily reach your stomach? Maybe they modified a lot or I misunderstood the workflow. :)
It's in slow release gel, so do you think it has some sticky properties or something? If it passed the first safety test, I wouldn't worry about it. As long as the surgery is done correctly.
 
https://www.businesswire.com/news/h...utics-Completes-Enrollment-Single-Dose-Safety
upload_2018-10-4_20-48-0.png
 
I am confused by their timeline. I thought they were already in phase 2 but actually no, they are just going to start phase 2 in 2019 and how many sub-phases are there going to be for the phase 2 as they speak of phase 2a?

Hopefully the final phase 3 will be quicker and the FDA approval process won't be too long.
 
I talked to the guy administering the trial in San Antonio.

He said the results will be posted on Frequency's website in December, probably around Christmas.

He said if it is a success, they will begin the next phase early next year; all high doses in clinics spread across the USA, not just San Antonio.
 
I am confused by their timeline. I thought they were already in phase 2 but actually no, they are just going to start phase 2 in 2019 and how many sub-phases are there going to be for the phase 2 as they speak of phase 2a?

Hopefully the final phase 3 will be quicker and the FDA approval process won't be too long.
I think it's going by fairly quickly. They produced good results and announced them last year before deciding to give us another trial less than a year after. If it continues at this rate, including their approach to strengthen the signals, we could have something in 2-3 years.
 
It's in slow release gel, so do you think it has some sticky properties or something?

I think it will stick everywhere around the middle ear and also at the part of the cochlea that reaches that area especially the oval window and after a while it will go into the fluid of the cochlea. The ratio between the sticky component and the active ingredient will be important - so I think they try to measure the highest dose and still have a sticky fluid that stays in the area as long as needed to go into the cochlea.

He said if it is a success, they will begin the next phase early next year; all high doses in clinics spread across the USA, not just San Antonio.

Thanks! That's a good news to begin the weekend! :)
 
"Hypothetical scenario"

If damaged auditory nerve fibers cause painful hyperacusis, and regenerating hair cells ends up giving patients cases of this awful condition, there will never a be a cure.

This worries me sick.
 
"Hypothetical scenario"

If damaged auditory nerve fibers cause painful hyperacusis, and regenerating hair cells ends up giving patients cases of this awful condition, there will never a be a cure.

This worries me sick.
Nerves have the ability to heal though. Right?
 
"Hypothetical scenario"

If damaged auditory nerve fibers cause painful hyperacusis, and regenerating hair cells ends up giving patients cases of this awful condition, there will never a be a cure.

This worries me sick.

Nerves can heal. Hyperacusis, as far as, I know isn't always due to nerve damage. Dr. Susan Shore talks about this in a lecture that can be found here on the forums and on YouTube. There are haircells that are for sound of certain frequencies and then there are haircells that are for sound amplification. And when the amplifying cells get damaged people get Hyperacusis. I might be off on the details here since it was a long time I saw the lecture but this is what I recall from it.
 
Nerves can heal. Hyperacusis, as far as, I know isn't always due to nerve damage. Dr. Susan Shore talks about this in a lecture that can be found here on the forums and on YouTube. There are haircells that are for sound of certain frequencies and then there are haircells that are for sound amplification. And when the amplifying cells get damaged people get Hyperacusis. I might be off on the details here since it was a long time I saw the lecture but this is what I recall from it.
Yes, the static noise of tinnitus and hyperacusis come from loss of outer hearing cells which focus more on amplification, while the pure tones of tinnitus are from the loss of inner hearing cells which focus on frequency/pitch like that of a piano.

That may explain why for a lot of us, we can still hear the tinnitus tone and match it.
 
I just saw that Frequency Therapeutics updated their clinical.gov description of FX-322. It happened a couple of days ago but does anyone know what they updated? I might've missed that part of discussion.
 
I just saw that Frequency Therapeutics updated their clinical.gov description of FX-322. It happened a couple of days ago but does anyone know what they updated? I might've missed that part of discussion.
Just that they are done with their enrollment for phase l/ll.
24 participants.
Somebody probably got their injection already!
 

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